Texas Pharmacy Law Update Laws...TSBP Laws and Rules Update March 3, 2016 Texas State Board of...
Transcript of Texas Pharmacy Law Update Laws...TSBP Laws and Rules Update March 3, 2016 Texas State Board of...
TSBP Laws and Rules Update March 3, 2016
Texas State Board of Pharmacy 1
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Texas State Board of Pharmacy
Laws and Rules Update
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• Please note: This course is accepted by the Texas State Board of Pharmacy for both general credit and as fulfilling the law requirement. However, it is NOT ACPE certified and will not appear in your CPE Monitor account.
Allison Vordenbaumen Benz, R.Ph., M.S.
Director of Professional Services
March 3, 2016
Texas Pharmacy Law Update
Goals
Review recent changes to pharmacy rules;
Review the most common Warning Notices
Issued to Pharmacies;
Review pharmacy related legislation passed
by the 2015 Legislature; and
Review some current issues facing the
Board.
TSBP Laws and Rules Update March 3, 2016
Texas State Board of Pharmacy 2
Board of Pharmacy Members
Jeanne D. Waggener, R.Ph.
President – Waco
Christopher M. Dembny, R.Ph.
Vice President – Richardson
Buford T. Abeldt, Sr., R.Ph.
Treasurer – Lufkin
L. Suzan Kedron
Dallas
Alice G. Mendoza, R.Ph.
Kingsville
Bradley A. Miller, Ph.T.R. Austin
Phyllis A. Stine
Abilene
Chip Thornsburg
San Antonio
Suzette Tijerina, R.Ph.
Castle Hills
Dennis F. Wiesner, R.Ph.
Austin
Jenny Downing Yoakum, R.Ph.
Kilgore
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Recently Adopted Rules
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Grounds for Discipline
Effective Date: December 6, 2015.
It is a ground for discipline of a
pharmacist or pharmacy technician if the
individual exhibits abusive, intimidating, or
threatening behavior toward a board
member or employee during the
performance of a member’s or
employee’s lawful duties.
Grounds for Discipline
Effective Date: Effective mid-March 2016.
It is a ground for discipline of a pharmacy
license if the owner, managing officer(s),
or other pharmacy employee(s) exhibits
abusive, intimidating, or threatening
behavior toward a board member or
employee during the performance of a
member’s or employee’s lawful duties.
Pharmacist-in-Charge
Effective Date: December 6, 2015.
A pharmacist-in-charge (PIC) of a Class A
Pharmacy may not also be the PIC of a:
– Class B Pharmacy; or
– Class C Pharmacy in a hospital with 101 beds
or more.
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Administration of
Immunizations and Vaccines
Effective Date: December 6, 2015.
Before preparing an immunization/vaccine
and between each patient contact:
– Pharmacist must:
cleanse their hands with an alcohol-based
waterless antiseptic hand rub; or
wash their hands with soap and water.
– If gloves are worn, pharmacists must change
gloves between patients.
Pharmacists and Pharmacy
Technicians
Pharmacist’s Continuing Education
Effective Date: March 17, 2013.
Pharmacists can receive credit for
programs approved by AMA as Category
1 CME.
Pharmacists must report 1-hour of CE
related to Texas Pharmacy Laws or
Regulations on renewals received after
1/1/15.
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Pharmacy Technician’s
Continuing Education
Effective Date: June 12, 2013.
Pharmacy Technicians must report 1-hour
of CE related to Texas Pharmacy Laws or
Regulations on renewals received after
1/1/15.
Pharmacy Technician’s
Continuing Education (cont.)
Effective Date: September 14, 2015.
Amendments to §297.8 (Continuing
Education) rules to:
– Decrease the number of in-service hours from
10 to 5 hours;
– Clarify the requirements for CE; and
– Clarify the types of programs that count for
continuing education.
Licensing Fee Changes
License Renewal Fee
Effective October 1, 2015 Change
Pharmacist $276 $25 decrease
Pharmacies $452 $80 decrease
Pharmacy Technicians $77 $19 decrease
Pharmacy Technician
Trainees $52 $10 decrease
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Conditions Receiving
"Warning Notices" FY2015
Number of Inspections
Class FY2015 % of FY2015
Inspections
Class A Pharmacies 2,275 76%
Class A-S 144 5%
Class B Pharmacies 5 <1%
Class C Pharmacies 268 9%
Class C-S 128 4%
Class D Pharmacies 95 3%
Class F Pharmacies 61 2%
Class G Pharmacies 15 <1%
Totals 2,991 100%
Warning Notices
Class # Pharmacies
Receiving WN % Receiving WN
Class A 992 77%
Class A-S 84 6%
Class B 2 <1%
Class C 80 6%
Class C-S 87 7%
Class D 31 2%
Class F 17 1%
Class G 0 N/A
Totals 1,293 100%
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Most Common Warning Notices
(All Classes of Pharmacy)
Violation Number of
WN Issued*
% of
Total WN
Records 731 9%
Sterile Preparations 647 29%
Pharmacy Technicians 564
Drug/Stock Environment 421 14%
Prescriptions 335 9%
Inventory 319 5%
* One pharmacy may receive multiple Warning Notice violations.
Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of WN
Issued Total
Records 731
Records Not Available 314
Absence of R.Ph. Record 66
Rx Not Separated 17
Rx Records Not Numerical Order 25
Improper Transfer of RX copies 3
Invoices Not Separated/Retrievable 122
Records for Non-Sterile
Compounds 169
No Written Information on RX 10
Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of
WN Issued Total
Sterile Preparations 647
No/Incomplete QA/QC 99
No/Incomplete P&P Manual 237
No/Inadequate Preparation Area 165
IV Preparation 131
No DUR 13
Cytoxic/Bio Procedures 2
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Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of
WN Issued Total
Pharmacy Technicians 564
No/Incomplete Training 510
No/Improper Supervision 19
Improper Registration 29
No Name Tags 6
Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of
WN Issued Total
Drug Stock/Environment 421
Improper Environment 137
Out-of-Date Drug Stock 158
Security 65
Unsanitary 32
Improper Drug Storage 20
Area for Non-Sterile Compounding 7
Violation of Limited Formulary 2
Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of
WN Issued Total
Prescriptions 335
Lack Proper Information 159
Prescription Label Incorrect 136
Official Rx Non-Compliance 40
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Most Common Warning Notices
(All Classes of Pharmacy) cont.
Condition Number of
WN Issued Total
Inventory 319
No Annual Inventory 84
No Change of Ownership Inventory 5
No Change of PIC Inventory 35
Incomplete Inventory 194
Improper Drug Destruction 1
Violations NOT Resulting
in Warning Notices
Individuals performing technician duties without
an active registration.
Technicians performing technician duties with
no pharmacist on site.
Technicians performing pharmacist-only duties
with no pharmacist on site (results in
emergency temporary suspension hearing).
Pharmacists who do not verbally counsel a
patient on a new prescription.
Violations NOT Resulting
in Warning Notices
Pharmacy is not able to produce 2 consecutive
annual inventories.
PIC falsifies response to a Warning Notice.
Pharmacies dispensing/shipping prescription
drugs into other states without holding a
pharmacy license in that state.
Pharmacies compounding sterile preparations
without proper licensure (e.g., Class A who
should have a Class A-S pharmacy license).
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Violations NOT Resulting
in Warning Notices
Egregious Conditions
– Dispensing CIIs pursuant to prescriptions not
issued on an Official Form;
– Excessive quantity of out-of-date stock (i.e.,
more than 25% of the inventory);
– Pharmacy closed and did not notify TSBP of
closing;
– Operating without a PIC for an extended
period of time (i.e., 3 months or more).
Violations NOT Resulting
in Warning Notices
Continuing threat – For example:
– Impaired pharmacist on duty; or
– Sterile compounding pharmacies who have
extensive non-compliance with Board Rule
291.133 and will not voluntarily agree to
“cease and desist” sterile compounding until
conditions have been corrected.
Both of these scenarios would result in an
Emergency Temporary Suspension Hearing.
Pharmacy Related
Legislation Passed by the
2015 Legislature
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S.B. 195 by Sen. Schwertner
This bill:
Moves the Prescription Monitoring
Program from the Department of Public
Safety (DPS) to the Board of Pharmacy;
and
Eliminates the Texas Controlled
Substance Registration program.
S.B. 195 by Sen. Schwertner
Effective Date: 6/20/2015 for some
provisions and 9/1/2016 for others.
This bill:
– Allows the Board, on or after 6/20/2015 to:
Adopt rules to implement the PMP and certain
other provisions related to prescriptions in the
Controlled Substances Act.
Sign a contract with a vendor to operate the PMP.
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S.B. 195 by Sen. Schwertner
February 2016 – Board adopted new
Chapter 315 to implement PMP and
provisions related to prescriptions in the
Controlled Substances Act.
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S.B. 195 by Sen. Schwertner (cont.)
On 9/1/2016:
– The Board will establish a program to fund the
Prescription Monitoring Program (PMP)
though a surcharge on the license fees of
persons authorized to access the PMP.
– The PMP is transferred from the DPS to
TSBP.
– The Controlled Substance Registration
program is abolished.
Timeline for Transfer of the PMP Program
November 2015 – RFP for the new PMP
issued by TSBP.
January 2016 – Appriss selected as the
vendor.
February – May 2016 – System installation
at TSBP.
May/June 2016 –Testing of program.
September 1, 2016 – NEW PMP goes live.
S.B. 460 by Sen. Schwertner
Effective Date: 9/1/2015.
This bill amends the Pharmacy Act to:
– Allow the Board to inspect financial records
relating to the operation of a pharmacy only in
the course of an investigation of a specific
complaint.
– Require a pharmacy to file an application to
change location at least 30-days prior to the
move.
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S.B. 460 by Sen. Schwertner (cont.)
Amends the Pharmacy Act to:
– Eliminate the Generic Substitution Sign and
modify the requirement for the Complaint
Notification to allow electronic posting.
– Specify that a pharmacy license may not be
renewed if it has expired for 91 days or more.
S.B. 460 by Sen. Schwertner (cont.)
Amends the Pharmacy Act for Class E
Pharmacies to:
– Allow the Board to discipline the pharmacy if it
has been disciplined in their state.
– Prohibit a person from owning the pharmacy if
their R.Ph. license was revoked, suspended,
restricted, surrendered in another state.
– Require the pharmacy to have a Texas
licensed pharmacist serve as the PIC for the
Texas license.
H.B. 751 by Rep. Zerwas
Effective Date: 9/1/2015.
The bill allows the substitution of
interchangeable biological products.
Interchangeable biological products are
those rated equivalent by FDA (Orange
Book and the Purple Book).
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H.B. 751 by Rep. Zerwas (cont.)
The bill specifies that not later than the
3rd business day after dispensing the
pharmacist must “communicate” to the
prescribing doctor the name of the
product provided and the manufacturer or
NDC number.
The bill outlines several methods to notify
the prescriber.
H.B. 751 by Rep. Zerwas (cont.)
Notification is not required if:
– There is no interchangeable biological product
approved by FDA; or
– A refill prescription is not changed from the
product dispensed on the prior dispensing.
The notification section of the bill expires
on 9/1/2019.
H. B. 1550 by Zerwas/Kolkhorst
Effective Date: 9/1/2015.
This bill amends the Pharmacy Act to:
Allow a pharmacists to administer
epinephrine, using an auto-injector, to a
patient in an emergency situation.
Specify a pharmacist may not receive
remuneration for the administration of
epinephrine but may seek reimbursement for
the cost of the epinephrine auto-injector.
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H. B. 1550 by Zerwas/Kolkhorst (cont.)
This bill amends the Pharmacy Act to:
– Specify that a pharmacist who administers
epinephrine through an auto-injector device is
not liable for civil damages if the pharmacist
acts in good faith and complies with Board
rules.
Current Issues
Sunset Review
Texas Pharmacy Act, Sec. 551.005.
Application of Sunset Act.
– The Texas State Board of Pharmacy is subject
to Chapter 325, Government Code (Texas
Sunset Act). Unless continued in existence as
provided by that chapter, the board is
abolished and this subtitle expires September
1, 2017.
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Sunset Review Time Line
August 2015.
– TSBP prepares a Self-Evaluation Report.
October 2015 – March 2016.
– Sunset staff reviews the agency.
Late March 2016.
– Sunset’s confidential report issued followed by
a joint meeting with TSBP to discuss
recommendations, followed by Sunset’s
formal request for agency written response.
Sunset Review Time Line (cont.)
April 2016. – Sunset staff report published.
May 2016. – Sunset Commission holds a public hearing to receive
public comment on the agency.
Summer 2016. – Commission decisions are issued.
January – May 2017. – 2017 Legislative Session
TSBP Website
www.pharmacy.texas.gov
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Receiving Credit
– Look for the quiz and evaluation to be posted in your Lifelong Learning Account 5-
7 days from now
An email notification will be sent to you when these are available
– You will have 30 days from the date they are posted to complete them.
– Complete these items to generate your certificate, which can be accessed at any
time through your Lifelong Learning Account.
Trouble accessing your Lifelong Learning Account?
Questions about your attendance?
Call the help desk:
1-800-215-0641
Select Option 1
Please note: This course is accepted by the Texas State Board of Pharmacy for both
general credit and as fulfilling the law requirement. However, it is NOT ACPE
certified and will not appear in your CPE Monitor account.
Final Reminders
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Thank You!
Thank you for your attendance!
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